The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-alcoholic Fatty Liver Disease

Tehran University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Fatty Liver; Insulin Resistance; Liver Dysfunction

Treatments: Drug: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01876108

1392/3/11- 589

Details and patient eligibility

About

The role of Helicobacter pylori(HP)in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

Full description

This randomized double blind clinical trial was performed in dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dyspeptic patients with positive antibody to H.pylori and
• persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion criteria

• alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
• heart disease (ischemic or congestive),
• hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
• renal disease (serum creatinine concentration of > 1.5 mg/dl),
• any severe systemic co-morbidities, neoplasm,
• using any hepatotoxic medication during the past 3 months,
• previous history of peptic ulcer,
• previous history of H.pylori eradication,
• existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and
• pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

H.pylori eradication

Experimental group

Description:

H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Treatment:

Drug: H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)

Lifestyle modification

No Intervention group

Description:

Obtaining ideal body weight by calorie restriction diet and programmed physical activity